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Forum participants expressed particular interest in pursuing various avenues of IL-7 investigation including: 1) Oncology, in association with chemo- and immunotherapy; 2) HIV infection, to reconstitute the immune system and trigger an anti-viral response, potentially limiting the incidence of AIDS-related and non-related pathologies; 3) HCV infection, to speed viral clearance and increase the proportion of patients able to clear the virus; and, 4) various other chronic infections such as tuberculosis.

That sounds great. Are you allowed to give any details with respect to your results and the trial itself(ie:viral load,cd4%,cd4 count, Adverse reactions, dosing schedule)? I fully understand that some trials ask the participants to keep info confidential, but if that is not the case, I'd love to hear the details.

my load stayed <50, it was just 3 injections (1 a week for three weeks) the highest my cd4 went was 225% above baseline, since oct. its been averaging around 80% from baseline. I'm in week 26 right now.

If your vl stayed below 50 after 3 injections for 26 weeks and you are not on any other ARVs, that's an amazing result ! What was your baseline cd4 count? How were your lipids? And no adverse reactions?

Sorry for all the questions but this therapy sounds very promising. It's nice to be able to discuss with someone who was actually in the trial.

Part of the protocol was that you had to be on ARV for at least 12 months before the trial (atripla for me) Lipids are slightly elevated. Adverse reactions were fever and malaise for up to 24 hours after injection and site reaction (rash) also liver enzymes were elevated (expected)

May I assume from your post above that the ARVs were stopped upon commencing the trial therapy and did the adverse effects straighten themselves out after the 24hrs. Also, what was the baseline cd4 count?

They are about ready to start the 30 microgram/kg part of the study from what i hear. They will have 10 people in that group. I was the only one at the center at 20micros in that phase so i have no idea what other results are/were. They will follow me for 48 weeks.

I actually know quite a few people that went through years of pretty bad IL-2 side effects, but kept doing it because their CD4s increased. Now we know those extra CD4s didn't do much of anything for them.

"Treatment with rhIL-7 also seems to have advantages over rhIL-2, explained Dr. Sportès. The expanded T cells retained significant functional capacity, and the CD4+ T cell expansion was not accompanied by a disproportionate increase in T regulatory cells, a phenomenon that has been observed after rhIL-2 therapy. Previous data have shown that in vivo IL-2 administration in humans has minimal effects on CD8+ T cell numbers, whereas rhIL-7 effects on CD8+ T cell expansion are at least comparable to the effects on CD4+ T cells."

This therapy, so far , doesn't seem to have the pitfalls of Il2. The trials will tell.

Just a quick update.....The IL-7 trial i was in is over for me ( Its been a year). I was able to maintain a 45% increase in CD4 levels with no obvious side effects. The 30ug study is currently underway.

9/15/09 - Cytheris Announces Interim Data from INSPIRE Study Showing Interleukin-7 (CYT107) Induces Dose-Dependent and Sustained Increase of CD4 T Cells in Chronic HIV-Infected Patients PARIS(BUSINESS WIRE) Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced presentation of data from an interim analysis of CLI-107-06 (INSPIRE), a Phase I/IIa study of HIV-infected patients with low CD4 T cell counts. The patients were treated with a three-injection cycle of the Company's investigative immune-modulator, recombinant human Interleukin-7 (CYT107). The analysis shows that CYT107 induces a dose dependent and sustained increase of CD4 T cells with many patients achieving CD4 counts > 500 cells/mm3. The INSPIRE data were presented during an oral late breaker session at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held September 12-15, 2009, in San Francisco, CA (Abstract H-1230a).

Even in the HAART era, it appears that low CD4 T cell counts place HIV infected persons at greater risk for a variety of serious morbidities. This study shows that treatment with IL-7 can increase CD4 T cell counts in many of these patients to levels that are within the normal? range. We now need to know whether these increased CD4 T cell counts confer protection from these serious complications,? said Michael M. Lederman, MD, the Scott R. Inkley Professor of Medicine at Case Western Reserve University, Cleveland, Ohio, Associate Director, CWRU/UHC Center for AIDS Research, and Chairman of the INSPIRE study.

The interim results with CYT107 closely mimic and even improve upon those seen in a recently published study1 in chronic HIV-infected patients treated with an earlier, non-glycosylated version (CYT 99 007) of Cytheris IL-7," said Yves Levy, MD, PHD, Scientific Director of the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) Vaccine Program, Service d'Immunologie Clinique, Hpital Henri Mondor, Crteil, France and Inserm, Presenter, Principle Investigator and Co-Chair of the INSPIRE study. "These results show that 3 injections of IL-7 are sufficient to expand naive and memory T cells in the long term. Further studies are needed to demonstrate whether these biological effects translate into clinical benefits.?

About the Study (CLI-107-06)

INSPIRE is a Phase I/IIa randomized placebo controlled, single-blind multicenter (Europe, US, and Canada) dose-escalation study of subcutaneous intermittent glycosylated Interleukin-7 (CYT107) in chronically HIV-infected patients with CD4 T-lymphocyte counts between 101-400 cells/mm3 and plasma HIV RNA< 50 copies/mL after at least 12 months of HAART. Patients selected in this trial are categorized as immunological low or non responders (INR), i.e. patients who have not optimally restored their immunity despite at least 12 months of HAART and with complete control of HIV replication.

INR patients represent from 5 to 30% of the HIV treated population, the prevalence of which depends on the definition criteria, which are used to characterize them. As shown in large cohorts, the risk of disease progression or death is significantly higher in the INR sub-population when compared to patients who achieve better T cell restoration.

Results: No clinical or laboratory side effects > grade 2 were recorded. In the 20g/kg group, 4 patients experienced a transient increase of HIV RNA values (<500 cp/mL in 3 of 4 and 1023 cp/mL in 1). The biological activity of CYT107 is shown below:

The design of the trial allows for an assessment of potential individual benefits in patients whose CD4 T cell count is suboptimal at baseline despite complete control of HIV replication under HAART. Such benefit may correspond to a sustained expansion of CD4 T cells, and potentially, a decrease in morbidity and mortality which is increased in this sub-population of patients compared to those who restore a higher CD4 T cell count after several months of HAART.

The interim analysis of INSPIRE data presented here further strengthens the potential role of CYT107 as a potent and safe immune modulator which is capable of dramatically increasing both CD4 and CD8 T cell counts in HIV-infected patients,? said Thrse Croughs, MD, Chief Medical Officer of Cytheris. The median CD4 and CD8 T cell increases per mm3 over baseline, from 240 to 563 (135%) and from 659 to 1210 (65%), respectively, at the 20mcg/kg dose, clearly indicate the potential of this cytokine to play a significant role in HIV therapy and more than justifies its further clinical development.?

Study to Focus on Immunotherapy for Treatment of Idiopathic CD4 Lymphocytopenia(ICL), a Rare Condition for Which No Treatment Currently ExistsPARIS--(Business Wire)--Cytheris SA, a clinical stage biopharmaceutical company focused on research anddevelopment of new therapies for immune modulation, today announced theinitiation of a Phase I/IIa ........

Thanks for the feedback Veritas. I have no idea on functionality as of yet. All i know is that I'm healthy. The increase at least makes me feel better mentally. A few years ago I was down to 125. I'll keep updating as i get more results.